FDA.reportPublic FDA data

Stress - Panic

Manufacturer
Newton Laboratories, Inc.
Effective date
2014-04-15
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 02:05:40

Label at a glance#

ProductStress - Panic
Active ingredientAconitum Napellus, Apis Mellifera, Arnica Montana, Arsenic Trioxide, Atropa Belladonna, Bellis Perennis, Bryonia Alba Root, Calendula Officinalis Flowering Top, Matricaria Recutita, Helianthemum Canadense, Ferrosoferric Phosphate, Histamine Dihydrochloride, Hypericum Perforatum, Strychnos Ignatii Seed, Daphne Mezereum Bark, Ornithogalum Umbellatum, Passiflora Incarnata Flowering Top, Phosphorus, Prunus Spinosa Flower Bud, Toxicodendron Pubescens Leaf, Lactic Acid, L-, Sulfur, Veratrum Album Root, Valerian
Label structure10 sections

Label contents#

Full prescribing information#

INDICATIONS & USAGE SECTION

Stress - Panic  Formulated for symptoms associated with stress and panic such as shock, anxiety, tension, fear or nervousness.

DOSAGE & ADMINISTRATION SECTION

Directions: ORAL USE ONLY -  Ages 12 and up, take 6 drops orally (ages 0 to 11, give 3 drops) as needed or as directed by a healthcare professional. Sensitive persons begin with 1 drop and gradually increase to full dose.

OTC - ACTIVE INGREDIENT SECTION

Aconitum nap. 15x, Apis mel. 15x, Arnica 15x, Arsenicum alb. 15x, Belladonna 15x, Bellis 15x, Bryonia 15x, Calendula 15x, Chamomilla 15x, Cistus canadensis 15x, Ferrum phosphoricum 15x, Histaminum hydrochloricum 15x, Hypericum 15x, Ignatia 15x, Mezereum 15x, Ornithogalum 15x, Passiflora 15x, Phos. 15x, Prunus spin. 15x, Rhus tox. 15x, Sarcolacticum ac. 15x, Sulphur 15x, Veratrum alb. 15x, Chamomilla 3x, Valeriana 3x.

OTC - PURPOSE SECTION

 Formulated for symptoms associated with stress and panic such as shock, anxiety, tension, fear or nervousness.

INACTIVE INGREDIENT SECTION

Inactive Ingredients: USP Purified Water; USP Gluten-free, non-GMO, organic cane dispensing alcohol 20%.  

QUESTIONS SECTION

OTC - QUESTIONS SECTION

www.newtonlabs.net  Newton Laboratories, Inc. FDA Est # 1051203 - Conyers, GA 30012
Questions?  1.800.448.7256

WARNINGS SECTION

Warning: Do not use if tamper - evident seal is broken or missing. Consult a licensed healthcare professional if pregnant, nursing or if symptoms worsen or persist for more than a few days. Keep out of reach of children.  

OTC - PREGNANCY OR BREAST FEEDING SECTION

Consult a licensed healthcare professional if pregnant, nursing or if symptoms worsen or persist for more than a few days. 

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

PACKAGE LABEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

package label
package label

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
63f39a63-5cd1-4016-bd86-2bbb0f6c3139Product name320240506
e5a77e9c-c528-733a-173d-914a234c024bProduct name520240506

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
55714-8001-12020-01-31C16284748780-19d75b9d0-a828-f424-e053-dadaa90a57ceStress - Panic

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55714-8001-1Stress - Panic29.57 mL in 1 BOTTLE, GLASSLIQUID29.571

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55714-8001STRESS - PANIC (ACONITUM NAP., APIS MEL., ARNICA, ARSENICUM ALB., BELLADONNA, BELLIS, BRYONIA, CALENDULA, CHAMOMILLA, CISTUS CANADENSIS, FERRUM PHOSPHORICUM, HISTAMINUM HYDROCHLORICUM, HYPERICUM, IGNATIA, MEZEREUM, ORNITHOGALUM, PASSIFLORA, PHOSPHORUS, PRUNUS SPIN., RHUS TOXICODENDRON, SARCOLACTICUM AC., SULPHUR, VERATRUM ALB., VALERIANA) LIQUID [NEWTON LABORATORIES, INC.]1Legacy NDC, 1 package rows20140429_72c6965b-9314-300a-0f1c-74aa01f30bb0.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
Aconitum NapellusACTIVE INGREDIENTU0NQ8555JD1
Apis MelliferaACTIVE INGREDIENT7S82P3R43Z1
Arnica MontanaACTIVE INGREDIENTO80TY208ZW1
Arsenic TrioxideACTIVE INGREDIENTS7V92P67HO1
Atropa BelladonnaACTIVE INGREDIENTWQZ3G9PF0H1
Bellis PerennisACTIVE INGREDIENT2HU33I03UY1
Bryonia Alba RootACTIVE INGREDIENTT7J046YI2B1
Calendula Officinalis Flowering TopACTIVE INGREDIENT18E7415PXQ1
Daphne Mezereum BarkACTIVE INGREDIENTX2N6E405GV1
Ferrosoferric PhosphateACTIVE INGREDIENT91GQH8I5F71
Helianthemum CanadenseACTIVE INGREDIENT46G3W789Q31
Histamine DihydrochlorideACTIVE INGREDIENT3POA0Q644U1
Hypericum PerforatumACTIVE INGREDIENTXK4IUX8MNB1
Lactic Acid, L-ACTIVE INGREDIENTF9S9FFU82N1
Matricaria RecutitaACTIVE INGREDIENTG0R4UBI2ZZ1
Ornithogalum UmbellatumACTIVE INGREDIENT9NS3M2Y78S1
Passiflora Incarnata Flowering TopACTIVE INGREDIENTCLF5YFS11O1
PhosphorusACTIVE INGREDIENT27YLU75U4W1
Prunus Spinosa Flower BudACTIVE INGREDIENT53Y84VPS2W1
Strychnos Ignatii SeedACTIVE INGREDIENT1NM3M2487K1
SulfurACTIVE INGREDIENT70FD1KFU701
Toxicodendron Pubescens LeafACTIVE INGREDIENT6IO182RP7A1
ValerianACTIVE INGREDIENTJWF5YAW3QW1
Veratrum Album RootACTIVE INGREDIENTQNS6W5US1Z1
Aconitum NapellusACTIVE MOIETYU0NQ8555JD1
Apis MelliferaACTIVE MOIETY7S82P3R43Z1
Arnica MontanaACTIVE MOIETYO80TY208ZW1
Arsenic Cation (3+)ACTIVE MOIETYC96613F5AV1
Atropa BelladonnaACTIVE MOIETYWQZ3G9PF0H1
Bellis PerennisACTIVE MOIETY2HU33I03UY1
Bryonia Alba RootACTIVE MOIETYT7J046YI2B1
Calendula Officinalis Flowering TopACTIVE MOIETY18E7415PXQ1
Daphne Mezereum BarkACTIVE MOIETYX2N6E405GV1
Ferrosoferric PhosphateACTIVE MOIETY91GQH8I5F71
Helianthemum CanadenseACTIVE MOIETY46G3W789Q31
HistamineACTIVE MOIETY820484N8I31
Hypericum PerforatumACTIVE MOIETYXK4IUX8MNB1
Lactic Acid, L-ACTIVE MOIETYF9S9FFU82N1
Matricaria RecutitaACTIVE MOIETYG0R4UBI2ZZ1
Ornithogalum UmbellatumACTIVE MOIETY9NS3M2Y78S1
Passiflora Incarnata Flowering TopACTIVE MOIETYCLF5YFS11O1
PhosphorusACTIVE MOIETY27YLU75U4W1
Prunus Spinosa Flower BudACTIVE MOIETY53Y84VPS2W1
Strychnos Ignatii SeedACTIVE MOIETY1NM3M2487K1
SulfurACTIVE MOIETY70FD1KFU701
Toxicodendron Pubescens LeafACTIVE MOIETY6IO182RP7A1
ValerianACTIVE MOIETYJWF5YAW3QW1
Veratrum Album RootACTIVE MOIETYQNS6W5US1Z1
AlcoholINACTIVE INGREDIENT3K9958V90M1

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 29 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
55714-800155714-8001-1

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 25 matching rows.

Name, UNII, Kind table
NameUNIIKind
Aconitum NapellusU0NQ8555JDACTIB
Apis Mellifera7S82P3R43ZACTIB
Arnica MontanaO80TY208ZWACTIB
Arsenic TrioxideS7V92P67HOACTIM
Atropa BelladonnaWQZ3G9PF0HACTIB
Bellis Perennis2HU33I03UYACTIB
Bryonia Alba RootT7J046YI2BACTIB
Calendula Officinalis Flowering Top18E7415PXQACTIB
Matricaria RecutitaG0R4UBI2ZZACTIB
Helianthemum Canadense46G3W789Q3ACTIB
Ferrosoferric Phosphate91GQH8I5F7ACTIB
Histamine Dihydrochloride3POA0Q644UACTIB
Hypericum PerforatumXK4IUX8MNBACTIB
Strychnos Ignatii Seed1NM3M2487KACTIB
Daphne Mezereum BarkX2N6E405GVACTIB
Ornithogalum Umbellatum9NS3M2Y78SACTIB
Passiflora Incarnata Flowering TopCLF5YFS11OACTIB
Phosphorus27YLU75U4WACTIB
Prunus Spinosa Flower Bud53Y84VPS2WACTIB
Toxicodendron Pubescens Leaf6IO182RP7AACTIB
Lactic Acid, L-F9S9FFU82NACTIB
Sulfur70FD1KFU70ACTIB
Veratrum Album RootQNS6W5US1ZACTIB
ValerianJWF5YAW3QWACTIB
Alcohol3K9958V90MIACT

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 1 · 59 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
AlcoholALCOHOL3K9958V90MINJECTION, SOLUTION / INTRAVENOUS6405 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSYRUP / ORAL21000 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSPRAY / TRANSDERMAL90 %w/vExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MLIQUID / INTRAMUSCULAR400 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSPRAY / SUBLINGUAL397 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MPASTE / DENTAL1.8 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MINJECTION, SOLUTION / INTRAMUSCULAR1000 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSUSPENSION / ORAL681 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MJELLY / VAGINALNAExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSUSPENSION / RECTAL0.35 %v/vExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MDROPS / ORAL210 mg/1mlExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MDROPS / NASAL10 mg/1mlExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MAEROSOL, SPRAY / TOPICAL561 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MGEL / TOPICAL9971 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MPOWDER, FOR SOLUTION / TOPICAL40 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MINJECTION / SUBCUTANEOUS149 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSOLUTION / TOPICAL2445 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MAEROSOL, METERED / RESPIRATORY (INHALATION)26664 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSOLUTION / OPHTHALMIC0.5 %w/vExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MGEL / DENTAL1.8 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MINJECTION / INTRAVENOUS92 %w/vExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSPRAY / TOPICAL3633 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSOLUTION / INTRAVESICAL7892 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSWAB / TOPICAL2250 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MINJECTION, SOLUTION / SUBCUTANEOUS6.1 %v/vExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MGEL, METERED / TOPICAL541 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSOLUTION / RESPIRATORY (INHALATION)0.08 %w/vExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MTABLET, DELAYED RELEASE / ORALNAExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MAEROSOL / NASAL20 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSOLUTION / DENTAL12.8 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSPRAY / NASAL20 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSOLUTION / INTRAVENOUS99 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MINJECTION, EMULSION / INTRAVENOUS520 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MINJECTION / INTRAVASCULAR100 %v/vExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSHAMPOO / TOPICAL714 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MAEROSOL, SPRAY / RESPIRATORY (INHALATION)35.75 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MLIQUID / INTRAVENOUS400 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MLIQUID / RESPIRATORY (INHALATION)5 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSOLUTION, CONCENTRATE / ORAL150.68 mg/1mlExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSOLUTION / TRANSDERMAL49.37 %w/vExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MLIQUID / ORAL3563 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MMOUTHWASH / BUCCAL200 mg/1mlExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MCONCENTRATE / ORAL198 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MELIXIR / ORAL13675 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSPRAY, METERED / SUBLINGUAL29 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MCONCENTRATE / BUCCAL679 mg/1mlExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MGEL / RECTAL898 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MCAPSULE, EXTENDED RELEASE / ORAL8 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MLOTION / TOPICAL25 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MINJECTION / INTRAMUSCULAR1491 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MCAPSULE / ORAL882 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MAEROSOL, FOAM / TOPICAL4504 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSOLUTION, CONCENTRATE / INTRAVENOUS4000 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MAEROSOL / TOPICAL561 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MGEL / TRANSDERMAL7360 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSOLUTION / ORAL6624 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MAEROSOL, METERED / NASAL70 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MGEL, METERED / TRANSDERMAL3675 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSOLUTION / NASAL10 mg/1mlExact identifier — unii candidate
59 equally ranked IID candidates

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
4a11b0df-0228-81ff-510f-20a7d05b4fc272c6965b-9314-300a-0f1c-74aa01f30bb02014-04-15WarningsExact identifier
spl id: 4a11b0df-0228-81ff-510f-20a7d05b4fc2
spl set id: 72c6965b-9314-300a-0f1c-74aa01f30bb0

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.